This might explain the recent strength:
News Alert from BusinessWire via Quote.com
Topic: (NASDAQ:ENMD) Entremed Inc,
Quote.com News Item #8099264
Headline: EntreMed Inc. Signs Partnership Agreement For GMP Production of
Endostatin Protein
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ROCKVILLE, Md.--(BW HealthWire)--Nov. 4, 1998--
Protein Scale-Up Manufacturing Underway for Human Clinical Trials
EntreMed Inc. (NASDAQ:ENMD) announced Wednesday that it has
signed a contract with Covance Biotechnology Services Inc., of
Research Triangle Park, N.C., to provide GMP (Good Manufacturing
Practices) production of Endostatin(TM) protein for further
preclinical and early clinical studies.
Endostatin(TM) protein, a naturally occurring fragment of
collagen XVIII, was isolated in 1996 by Dr. Michael O'Reilly in the
laboratory of Dr. Judah Folkman at Children's Hospital, Boston, a
teaching affiliate of the Harvard Medical School.
In preclinical studies in mice, Endostatin(TM) protein has
repeatedly inhibited the growth of metastatic and primary cancerous
tumors with no drug resistance or toxicity noted.
EntreMed and Covance began technology transfer for the production of Endostatin(TM) protein in the second quarter of this year. With the technology transfer process now complete, EntreMed and Covance have jointly demonstrated success in numerous small and medium-scale fermentation runs.
It is anticipated that Covance's larger scale GMP production will be
required for initiation and expansion of clinical studies.
Dr. John W. Holaday, EntreMed chairman, president and chief
executive officer commented on the partnership, "We are proud of our
rapid progress in the scale up of Endostatin(TM) protein and continue to
be encouraged by the increased production yields from our Pichia pastoris
expression system. We are pleased to report that human recombinant
Endostatin(TM) protein is readily synthesized and purified from this
system."
The first runs at the 140-liter scale will provide material for
the completion of existing preclinical studies. Larger GMP
fermentations at the 2000-liter scale are scheduled to commence at
Covance in early 1999. Under the terms of the agreement, Covance will
produce enough human recombinant Endostatin(TM) protein to cover the early
clinical trials projected to commence next year.
Dr. Edward R. Gubish Jr., senior vice president for Research and
Development at EntreMed, commented on Endostatin(TM) production, "As this
soluble Endostatin(TM) protein is being produced and tested in the
clinical setting, EntreMed will continue to pursue the development of
Endostatin(TM) protein on an increasingly larger scale to provide material
for expanded clinical studies and commercialization."
In the first half of 1997, EntreMed began its production of human
recombinant Endostatin(TM) protein in shaker flasks at its Rockville
facility. This method was expanded to a small bioreactor at the 15-liter
scale in the fourth quarter of 1997.
After producing Endostatin(TM) protein in four expression
systems, EntreMed scientists selected the Pichia expression system
because it provided the highest yields and most promising levels of
activity.
In the Spring of 1998, EntreMed developed a relationship with the
Bioprocess Development Facility at the University of Nebraska-Lincoln to
produce Pichia-derived Endostatin(TM) protein at the 60-liter scale. The
60-liter batches of Endostatin(TM) protein produced at the University of
Nebraska provided material for preclinical toxicology and efficacy studies
conducted by the Company.
Pichia-derived Endostatin(TM) protein has repeatedly demonstrated
activity and efficacy in preclinical in vitro and in vivo mouse studies
conducted in the laboratories of EntreMed, Children's Hospital, Boston,
and other independent collaborators.
Bryan Lawlis, Ph.D., president and CEO of Covance Biotechnology
Services, commented on the agreement: "Covance is pleased to work with
EntreMed in the development of this promising protein. Our expertise in
GMP production of complex biological compounds may help accelerate the
development of this unique treatment of cancerous tumors."
Covance, with headquarters in Princeton, N.J., is one of the
world's largest and most comprehensive drug development service
companies, with 1997 revenues of approximately $590 million,
operations currently in 17 countries, and approximately 6,900
employees worldwide. Covance's purpose is to lead advancements in drug
development through science, service and shaping solutions.
Rockville-based EntreMed Inc., The Angiogenesis Company(TM), is a
leader in the field of antiangiogenesis research, which involves the
inhibition of abnormal blood vessel growth recently associated with a
broad range of diseases.
The Company's strategy is to accelerate development of its core
technologies through collaborations and sponsored research programs
with university medical departments, research companies and government
laboratories.
For further information, please visit the EntreMed web site at
www.entremed.com.
Key Term Used in This Release
Pichia Pastoris: A methylotropic yeast that has the capability of
secreting large quantities of foreign proteins into the fermentation broth
in which it survives. Pichia pastoris is an industry accepted production
system already being used for several protein-based biopharmaceutical
agents currently in clinical trials.
Statements herein that are not descriptions of historical facts
are forward-looking and subject to risk and uncertainties.
Actual results could differ materially from those currently
anticipated due to a number of factors, including those set forth in
the Company's Securities and Exchange Commission filings under "Risk
Factors," including risks relations to the early stage of products
under development; uncertainties relating to clinical trials;
dependence on third parties; future capital needs; and risks relating to
the commercialization, if any, of the company's proposed products (such as
marketing, safety, regulatory, patent, product liability, supply,
competition and other risks).
CONTACT: EntreMed Inc.
Mary P. Sundeen, Director of Research Operations
301/738-2490
KEYWORD: MARYLAND NEW JERSEY
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL
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